(262 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and conformance to standards for a naso-jejunal tube, with no mention of AI or ML.
No
The device is used for administration of medication, which implies it's a delivery mechanism for a therapeutic agent, rather than being therapeutic itself.
No
Explanation: The device is described as providing "short-term enteral access for administration of medication to the small intestine," which indicates a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical naso-jejunal tube made of polyurethane with a stylet, indicating it is a hardware medical device.
Based on the provided information, the AbbVie NJ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide "short-term enteral access for administration of medication to the small intestine." This is a therapeutic and delivery function, not a diagnostic one. IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a physical tube for insertion into the body. This aligns with a medical device used for treatment or delivery, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostics.
The device is clearly intended for direct interaction with the patient's body for the purpose of delivering medication, which falls under the category of a medical device, but not specifically an IVD.
N/A
Intended Use / Indications for Use
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small intestine, through the nose
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The performance characteristics of the AbbVie NJ have been verified based on the conformance to applicable industry standards. The material composition of the Abb Vie NJ shows acceptable performance across all biocompatibility protocols tested per ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation und testing within a risk management process. The AbbVic NJ was assessed for conformance to standard BS EN 1615:2000 Enteral feeding catheters and enterul giving sets for single use and their connectors - Design and testing. An assessment of the AbbVie NJ has been completed and shown to be acceptable per ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements.
Clinical Performance Data: No clinical evaluations were performed or relied upon for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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K133129 Page 1 of 3
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| abbvie | AbbVie NJ K133129 |
|---|---|
| Traditional 510(k) Notification | |
| 510(k) Summary |
510(k) Summary
Sponsor:
AbbVie Inc. 1 N. Waukegan Road North Chicago, IL 60064
Contact:
Katherine Wortley, Ph.D. Director Regulatory Affairs AbbVie Inc. Telephone: (847) 938-7707 Fax: (847) 775-4997 Email: katherine.wortley@abbvie.com
Date Prepared:
September 30, 2013
Device:
| Trade Name: | AbbVie™ NJ |
|---|---|
| Common Name: | Naso-Jejunal Tube |
| Classification: | Tubes, Gastrointestinal and Accessories |
| Name: | 21 CFR 876.5980, Product Code KNT, Class II |
Entriflex™ Feeding Tube, K833621 Predicate Device:
Device Description:
The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.
1
AbbVie NJ K133129 abbvie Traditional 510(k) Notification 510(k) Summary
Device Intended Use:
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
Comparison of Product Characteristics:
The AbbVie NJ is substantially equivalent to the currently marketed predicate device, Entriflex Feeding Tube (K833621). Both devices are naso-enteric tubes. The tubes have the same fundamental structure and function. The predicate is a family of devices that vary in diameter (8, 10, and 12 FR) and length. The AbbVie NJ tube diameter (10 FR) falls within the range of the Entriflex product family. Duration of use (30 days or less), stylet feature, tube material (polyurethane), and anatomical delivery (through the nose into the small intestine) are the same as the predicate. Differences include tube length, distal end configuration, proximal end connector type, and sterility status. The indication for use for the AbbVie NJ (administration of medication) is within the indications for use of the Entriflex Feeding Tube (administration of feeding, fluid and medication).
Non-Clinical Performance Data:
The performance characteristics of the AbbVie NJ have been verified based on the conformance to applicable industry standards. The material composition of the Abb Vie NJ shows acceptable performance across all biocompatibility protocols tested per ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation und testing within a risk management process. The AbbVic NJ was assessed for conformance to standard BS EN 1615:2000 Enteral feeding catheters and enterul giving sets for single use and their connectors - Design and testing. An assessment of the AbbVie NJ has been completed and shown to be acceptable per ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements.
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2
3
AbbVic NJ K133129 abbvie Traditional 510(k) Notification 510(k) Summary
Clinical Performance Data:
No clinical evaluations were performed or relied upon for the determination of substantial equivalence.
Conclusion:
The information provided within this pre-market notification demonstrates that the AbbVie NJ has no differences that would affect the safety or effectiveness of the device as compared to the predicate device, Entriflex Feeding Tube. The differences between the two devices do not raise new issues of safety or effectiveness. The AbbVie NJ is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2014
AbbVie, Inc. Katherine Wortley, Ph.D., RAC Director Regulatory Affairs 1 N. Waukegan Road North Chicago, IL 60064
Re: K133129
Trade/Device Name: AbbVie™ NJ Regulation Number: 21 CFR 8 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 15, 2014 Received: May 16, 2014
Dear Katherine Wortley,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r case ve actised that I Bromination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Katherine Wortley, Ph.D., RAC
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -A
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K133129
Device Name: AbbVie™ NJ
Indications for Use:
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
Prescription Use X
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lern 2014.06.19 1